CMC Regulatory Affairs Associate Director and Line Manager

Do you want to combine your scientific background with your passion for people and talent development?

We are looking to recruit a leader in our Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs, Submission Excellence team at Associate Director Line Manager level to support and lead a team of Regulatory professionals which is responsible for managing CMC submissions across the product lifecycle. The position is permanent and based in either Södertälje, Sweden or Macclesfield, UK

Our Södertalje site in the county of Stockholm is host to one of the largest manufacturing units of pharmaceuticals in the world – and the largest in all of AstraZeneca. It’s no wonder we’re known as the ‘heart of production’. From chemical production, formulation and packing, to marketing, sales, and delivery, on this site, we handle the whole process.

Macclesfield is a vibrant and successful campus, with 101 acres dedicated to science, technology and manufacturing excellence. As an advanced manufacturing and development campus, Macclesfield has 4,000 talented people covering the widest range of vital roles – it is the biggest pharmaceutical manufacturing site in the UK, the base for our second largest global IT hub and the home of Pharmaceutical Technology, Global Quality and Supply Chain & Strategy teams. We seamlessly blend scientific knowledge, state-of-the-art technology and advanced manufacturing expertise in a cohesive environment where the energy and pioneering spirit of our people thrives.

Our Chemistry, Manufacturing, and Controls (CMC) Regulatory functions span across the product lifecycle and are responsible for the regulatory strategy relating to the development, manufacture and testing of all our medicines. With our expertise we interpret, anticipate and shape global Health Authority expectations to create insightful CMC and Device Regulatory Strategies. We are the bridge between our R&D functions, Operations sites, Quality and Global Supply Teams in helping safe, effective medicines reach the right patient at the right times.

What you’ll do
In this Associate Director/Line manager role you will possess strategic leadership skills and will be accountable for leading a team of Regulatory professionals. You will provide overall direction and be accountable for people management and development to ensure delivery of global CMC regulatory submissions for a product/group of products across the product lifecycle based on the needs identified by the business, markets and patients.

You will apply Lean Principles to ways of working and foster a positive working environment that supports continuous improvement and simplifications to drive and promote one way of working across the CMC RA Submission Excellence organisation. You will manage complex situations to ensure correct prioritisation in order to deliver the needs of the AZ business, the customer and the future direction of CMC RA. You will provide high level strategic, operational and tactical regulatory CMC expertise and direction to AstraZeneca product team in support of drug products. Additional accountabilities:

• Accountable for recruitment, skill-development, coaching, and performance feedback of team members

• Accountable for working collaboratively with peer line manager to ensure consistent ways of working with AZ line management policies and decisions

• Accountable for taking a holistic AZ perspective in decision making in e.g. complex resource situations

• Ensure project activities managed within the team are delivered to a high standard, agreed time scales and meet the AZ business requirements, compliance requirements and regulatory authority expectations worldwide

• Accountable for delivering the CMC Regulatory Submissions for a complex portfolio of drug projects across the product lifecycle. Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.

• Have an understanding of regional and/or global regulatory science and overall drug/biologic development processes and strategies

• Lead cross business non-drug projects and act as business owner for critical business processes to ensure accelerated submissions, support launch activities and management of regulatory information and ensure regulatory compliance on behalf of AZ

• Manage risk by making complex judgements, developing innovative solutions and applying a comprehensive cross-functional and industry understanding. Monitor changes in the global regulatory environment and oversee process for incorporation emerging trends into effective submission strategies

• Assist in budget management and drive resource planning and coordinating the appropriate deployment of CMC RA staff to appropriate cross functional teams in consultation with the relevant function managers. Regularly review such allocation to ensure optimum utilisation and development of CMC staff

• Lead knowledge sharing and provide coaching both within CMC RA and possibly to other AZ functions or external to AZ

• Accountable for the delivery of regulatory initiatives and improvement programs aimed at ensuring compliance, continuous improvement, enhancing commitment to quality and improving profitability, ensuring that policy and standards meet regulatory requirements

• Will have a high level of interactive communication to set clear direction for the global staff, directly advising and influencing others at a high level

You thrive with the opportunity to build effective cross functional networks and actively contribute to unit Leadership Team, having a strategic mind and thinking proactively.

Essential for the role

• At least a Bachelor’s degree in a science related field and/or other appropriate knowledge/experience

• Broad background of experience working in pharmaceutical business

• Proven leadership and program management experience

• Ability to think strategically and critically evaluate risks to regulatory activities.

• Ability to work strategically within a complex, business critical and high-profile development program

• Must demonstrate competencies of: strategic thinking, strategic influencing, innovation, initiative, leadership, decision making and excellent oral and written communication skills

Desired for the role

• Proven track record of independently managing complex managerial tasks

• Prior experience within regulatory affairs and/or CMC

• Proven track record of coaching and delegation capabilities

• Experience of people management

Why AstraZeneca?
Our purpose is ambitious and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate forward thinking and act with a sense of urgency. We are ambitious, take informed risks and learn from both success and failure. We are curious, creative and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Are you ready to move forward in your career?

Join us and be part of an outstanding place to work; an environment that energizes and empowers each of us to achieve our personal and organisational goals!

So, what’s next?
Are you already imagining yourself in this position? Good, because we can’t wait to hear from you!

Welcome with your application; CV and cover letter, no later than 30th January, 2023.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.